Package Insert: Information for the User

Loratadine Tarbis 10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Loratadina Tarbis belongs to a class of medications called antihistamines, used for the treatment of various allergic processes.

Loratadina Tarbis is indicated for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) and perennial (allergy symptoms throughout the year).

These symptoms may include sneezing, nasal discharge, nasal itching, as well as eye irritation, itching, and tearing.

Loratadina Tarbis is also indicated for the relief of symptoms of chronic idiopathic urticaria (skin eruption consisting of urticaria and papules).

Do not take Loratadina Tarbis 10 mg tablets:

• If you are allergic to loratadine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadina Tarbis:

• If you have severe liver disease.

Interference with analytical tests

If you are to undergo any type of skin test for allergy. Do not take Loratadina Tarbis during the 2 days prior to the test, and inform your doctor because this medication may alter the test results.

Use of Loratadina Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

When taken simultaneously, some medications may increase the level of loratadine in the blood and may cause adverse effects.

Interactions may occur with all CYP3A4 or CYP2D6 inhibitors such as the following:

• Ketoconazole (used to treat fungal infections)
• Erythromycin (an antibiotic)
• Cimetidine (used to treat stomach acid).

Taking Loratadina Tarbis with food, drinks, and alcohol

Loratadina Tarbis can be taken with or without food. Avoid consuming alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Loratadina Tarbis is not recommended for use during pregnancy or breastfeeding, as loratadine passes into breast milk.

Driving and operating machinery

This medication may cause drowsiness or reduce reaction time in some people. Therefore, it is recommended not to perform tasks that require special attention (such as driving or operating machinery) until you know how this medication affects you.

Loratadina Tarbis contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the medication administration instructions indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual Dose

Adults/Children over 12 years: 10 mg once a day (one tablet once a day).

Children between 2 and 12 years and with a weight over 30 kg: 10 mg once a day (one tablet once a day).

Children over 2 years but weighing no more than 30 kgshould nottake this medication.

These tablets should not be given to children under 2 years of age.

Patients with severe liver problems:

Patients with severe liver problems

Your doctor may prescribe a different dose if you have severe liver problems.

If you take more Loratadina Tarbis 10 mg tablets than you should

If you take more Loratadina Tarbis than you should, you may experience drowsiness, rapid heartbeats, and headaches

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91562 04 20 indicating the medication and the amount ingested.

If you forgot to take Loratadina Tarbis

If you forgot to take your dose on time, take it as soon as possible, and then return to your usual dosing schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Loratadina Tarbis

Your doctor will indicate the duration of treatment. Do not interrupt treatment if you feel better, as symptoms may reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Loratadina Tarbis may produce adverse effects, although not everyone will experience them.

If you develop an allergic reaction to this medication, you must immediately stop treatment with Loratadina Tarbis and consult with your doctor.

This allergic reaction may consist of:

• skin rash (including the inside of the mouth)
• itching
• inflammation of the face/tongue/lips/hands/feet
• difficulty breathing

Rarely, some patients may develop nausea (urge to vomit), fatigue, headache, drowsiness, nervousness, dry mouth, and hair loss. These adverse reactions are generally mild and resolve on their own.

Other adverse reactions described when taking Loratadina were dizziness, increased heart rate, palpitations (sensation of increased heart rate), stomach wall irritation (gastritis), increased appetite, insomnia, skin rashes, and liver disorders.

Adverse effects with unknown frequency (cannot be estimated from available data) have been cases of weight gain.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the carton after CAD.

The expiration date is the last day of the month indicated.

Do not use this medication if you observe any change in the appearance of the tablet.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loratadina Tarbis 10 mg tablets

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch and magnesium stearate.

Appearance of the product and contents of the packaging

The tablets are white, round, flat and scored.

Each package contains 20 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of this leaflet:January 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.